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    EudraCT Number:2017-003728-64
    Sponsor's Protocol Code Number:E2027-G000-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-02
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-003728-64
    A.3Full title of the trial
    A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies
    Estudio aleatorizado, controlado con placebo, doble ciego y de grupos paralelos para evaluar la eficacia, seguridad y tolerabilidad de E2027 en pacientes con demencia con cuerpos de Lewy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    E2027 for the treatment of Dementia With Lewy Bodies
    E2027 para el tratamiento de la demencia con cuerpos de Lewy
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberE2027-G000-201
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEisai Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEisai Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Ltd.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressMosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00448456761400
    B.5.5Fax number00448456761486
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code E2027
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Yet Assigned
    D.3.9.1CAS number 1630083-70-3
    D.3.9.2Current sponsor codeE2027 Maleate
    D.3.9.3Other descriptive nameE2027
    D.3.9.4EV Substance CodeSUB191555
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dementia With Lewy Bodies
    Demencia con cuerpos de Lewy
    E.1.1.1Medical condition in easily understood language
    Dementia with Lewy bodies: A form of dementia with abnormal proteins (Lewy bodies) accumulating in the brain, and symptoms include impaired memory, concentration, visual hallucinations.
    Es una forma de demencia con proteínas anormales (cuerpos de Lewy) que se acumulan en el cerebro y que producen síntomas tales como deterioro de la memoria, concentración y alucinaciones visuales.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067889
    E.1.2Term Dementia with Lewy bodies
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1- To determine whether E2027 is superior to placebo on the cognitive endpoint of MoCA
    in subjects with DLB after 12 weeks of treatment
    2- To determine whether E2027 is superior to placebo on the global clinical endpoint of
    CIBIC-Plus after 12 weeks of treatment
    • Determinar si E2027 es superior a placebo respecto al criterio de valoración cognitivo de la Evaluación Cognitiva Montreal (MoCA) en pacientes con demencia con cuerpos de Lewy (DCL) tras 12 semanas de tratamiento
    • Determinar si E2027 es superior a placebo respecto al criterio de valoración clínica global de Impresión del Cambio Basado en la Entrevista del Médico más la Información Aportada por el Cuidador (CIBIC-Plus) tras 12 semanas de tratamiento
    E.2.2Secondary objectives of the trial
    1- To evaluate the safety and tolerability of E2027 in subjects with DLB
    2- To determine whether E2027 is superior to placebo on the following secondary endpoints
    after 12 weeks of treatment:
    - Neuropsychiatric Inventory (NPI)
    - Mini-Mental State Examination (MMSE)
    - Cognitive Fluctuation Inventory (CFI)
    - Clinician Global Impression of Change in Dementia with Lewy Bodies (CGIC-DLB)
    3- To characterize the population pharmacokinetics (PPK) of E2027 in subjects with DLB, including evaluation of the effects of intrinsic and extrinsic factors on E2027 PK
    • Evaluar la seguridad y tolerabilidad de E2027 en pacientes con DCL
    • Determinar si E2027 es superior al placebo respecto a los siguientes criterios de valoración secundarios tras 12 semanas de tratamiento:
    - Inventario Neuropsiquiátrico (NPI)
    - Mini-examen del estado mental (MMSE)
    - Inventario de fluctuación cognitiva (CFI)
    - Impresión clínica global del cambio en la demencia con cuerpos de Lewy (DLB-CGIC)
    • Caracterizar la farmacocinética poblacional (FCP) de E2027 en pacientes con DCL, incluyendo la evaluación de los efectos de factores intrínsecos y extrínsecos en la farmacocinética (FC) de E2027
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age 50 to 85 years, inclusive at time of consent.
    2. Meet criteria for probable DLB (as defined by the 4th report of the DLB Consortium)
    (Appendix 1). Specific situations regarding the use the imaging are described below:
    a. have 1 core clinical feature only by the investigator and who did not have previous reports of DAT brain imaging scan, MIBG scan or polysomnography (PSG) will undertake DAT brain imaging scan or MIBG scan as organized by the investigator.
    b. have 2 or more core clinical features by the investigator but who are judged as having only 1 core clinical feature by central reviewer and who did not have previous reports of DAT brain imaging scan, MIBG scan or PSG may undertake DAT brain imaging scan or MIBG scan after discussion with the sponsor medical monitor.
    c. have 2 or more core clinical features by the investigator and the central reviewer and who did not have previous reports of DAT brain imaging scan, MIBG scan or PSG may undertake DAT brain imaging scan or MIBG scan after discussion with the sponsor medical monitor if the investigator considers that imaging is necessary to confirm the diagnosis.
    3. MMSE >14 and <26 at Screening Visit.
    4. Has experienced visual hallucinations during the past 4 weeks before Screening Visit.
    5. If receiving AChEIs, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment-naïve subjects can be entered into the study but there should be no plans to initiate treatment with AChEIs from Screening to the end of the study.
    6. Must have an identified caregiver or informant who is willing and able to provide follow-up information on the subject throughout the course of the study. This person must, in the opinion of the investigator, not be suffering from cognitive impairment, be sufficiently familiar with the subject and spend sufficient time with the subject on a regular basis such that the caregiver or informant can reliably fulfill the study requirements and must provide separate written consent. The caregiver or informant should normally be residing with the subject. If the caregiver or informant is not residing with the subject, the investigator has to be satisfied that the subject can contact the caregiver or informant readily during the times when the caregiver or informant is not with the subject. As a guide the caregiver or informant should have contact with the subject on at least 4 days a week and each day for a total of at least 5 hours. If in doubt about whether a subject's care arrangements are suitable for inclusion, the investigator should discuss this with the medical monitor. At all visits caregivers or informants need to attend the visit in person along with the subject. If during the study, the designated caregiver or informant relinquishes his/her responsibilities as caregiver or informant, a replacement caregiver or informant who meets the criteria above and who has similar knowledge of the subject’s clinical status from Baseline throughout the Treatment Period must be found. If no such replacement caregiver or informant is available, the subject must be discontinued from the study.
    7. Provide written informed consent. If a subject lacks capacity to consent in the investigator's opinion, the subject's assent should be obtained, as required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations). In countries where local laws, regulations, and customs do not permit subjects who lack capacity to consent to participate in this study, they will not be enrolled.
    1. Hombre o mujer de 50 a 85 años de edad inclusive en el momento de dar su consentimiento.
    2. Cumplir los criterios de probable DCL (de acuerdo con la definición del 4.º informe del Consorcio para la DCL). A continuación se describen situaciones específicas relativas al uso de los estudios de representación por imágenes:
    a. si, según el investigador, presenta una sola característica clínica esencial y no dispone de informes previos de un estudio de imagen cerebral del DAT, una gammagrafía con MIBG o una polisomnografía (PSG), se realizará un estudio de imagen cerebral del DAT o una gammagrafía con MIBG, a criterio del investigador.
    b. si, según el investigador, presenta dos o más características clínicas esenciales, pero el revisor central considera que solo presenta una característica clínica esencial y no dispone de informes previos de un estudio de imagen cerebral del DAT, una gammagrafía con MIBG o una PSG, se podrá realizar un estudio de imagen cerebral del DAT o una gammagrafía con MIBG tras comentarlo con el monitor médico del promotor.
    c. Si, según el investigador y el revisor central, presenta dos o más características clínicas esenciales y no dispone de informes previos de un estudio de imagen cerebral del DAT, una gammagrafía con MIBG o una PSG, se podrá realizar un estudio de imagen cerebral del DAT o una gammagrafía con MIBG tras comentarlo con el monitor médico del promotor si el investigador considera que el estudio de representación por imágenes es necesario para confirmar el diagnóstico.
    En el caso de que existan requisitos legales locales/nacionales de revisión obligatoria central adicional de la exposición a la radiación para el uso de DAT/MIBG, la inclusión de pacientes se limitará a los que no necesiten la realización de una nueva exploración por DAT/MIBG para este estudio (es decir, los pacientes de los que se disponga DAT/MIBG o resultados de scan/ PSGhistóricos, o pacientes que presenten 2 características clínicas esenciales de DCL) hasta que la autoridad reguladora de la exposición a la radiación conceda tal aprobación. A partir de entonces, la inclusión de pacientes se ampliará a los que podrían necesitar la realización de una nueva exploración por DAT/MIBG para este estudio (revisado conforme a la Enmienda 01).
    3. MMSE >14 e <26 en la visita de selección.
    4. Ha experimentado alucinaciones visuales durante las 4 semanas anteriores a la visita de selección.
    5. Si está recibiendo IACE, la dosis debe haberse mantenido estable durante al menos 12 semanas antes de la visita de selección, sin que se prevean ajustes de dosis durante el estudio. Los pacientes no tratados previamente se pueden incluir en el estudio, pero no se debe haber programado iniciar tratamiento con un IACE entre la selección y el final del estudio.
    6. Debe tener un cuidador o informante identificado que esté dispuesto y sea capaz de proporcionar información de seguimiento sobre el paciente durante todo el estudio. Esta persona, en opinión del investigador, no debe padecer ningún deterioro cognitivo, debe estar suficientemente familiarizado con el paciente y pasar tiempo suficiente con él de manera habitual, de forma que el cuidador o el informador pueda cumplir de manera fiable los requisitos de estudio, y dará su consentimiento por escrito separado. El cuidador o informante debe convivir habitualmente con el paciente. Si el cuidador o informante no convive con el paciente, el investigador tendrá que conformarse con que el paciente pueda contactar fácilmente con el cuidador o informante durante el tiempo en el que este no esté con el paciente. Como orientación, el cuidador o informante debe mantener contacto con el paciente al menos 4 días a la semana y durante un total de al menos 5 horas al día. En caso de duda sobre si las medidas de atención del paciente son adecuadas para su inclusión en el estudio, el investigador lo comentará con el monitor médico. En todas las visitas, el cuidador o informante deberá acudir personalmente a la visita junto con el paciente. Si durante el estudio, el cuidador o informante designado renuncia a sus responsabilidades como cuidador o informante, se deberá encontrar a un cuidador o informante sustituto que cumpla los criterios anteriores y tenga un conocimiento similar del estado clínico del paciente desde el inicio y a lo largo de todo el periodo de tratamiento. Si no se cuenta con ese cuidador o informante sustituto, se retirará al paciente del estudio.
    7. Otorgar el consentimiento informado. Si, en opinión del investigador, un paciente carece de capacidad para dar su consentimiento, se obtendrá su asentimiento conforme a la legislación, la normativa y las costumbres locales, y además se obtendrá el consentimiento informado por escrito del representante legal. En los países en los que la legislación, las normativas y las costumbres locales no permitan que las personas sin capacidad para dar su consentimiento participen en este estudio, no se les incluirá.
    E.4Principal exclusion criteria
    1. Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the subject’s DLB, including any comorbidities detected by clinical assessment or MRI.
    2. History of transient ischemic attacks or stroke within 12 months of Screening.
    3. Modified Hachinski Ischemic Scale >4.
    4. Parkinsonian (extrapyramidal) features with Hoehn & Yahr stage IV or higher.
    5. Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V).
    6. GDS score >8.
    7. Evidence of other clinically significant lesions that suggest a dementia diagnosis other than DLB on brain MRI at Screening. All MRIs will be acquired using a standardized procedure that will
    be outlined in the Imaging Charter and Imaging Acquisition Guidelines (IAG) and will be read by an approved centralized reader.
    8. Other significant pathological findings on brain MRI at Screening, including but not limited to: any macrohemorrhage (greater than 10 mm at greatest diameter); an area of superficial siderosis; evidence of cerebral contusion, encephalomalacia, aneurysms, arteriovenous malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel or white matter disease; space occupying lesions; or brain tumors [however, lesions diagnosed as meningiomas or arachnoid cysts and less than or equal to 1 cm at their greatest diameter need not be exclusionary])
    9. Hypersensitivity to E2027 or any of the excipients.
    10. A prolonged corrected QT interval calculated using Fridericia’s formula (QTcF) as demonstrated by triplicate ECG at the Screening or Baseline Visit (ie, mean value >450 msec).
    11. Had symptomatic orthostatic hypotension or symptomatic orthostatic tachycardia which resulted in hospitalization or urgent medical review in hospital in the past 12 months before Screening.
    12. Has a “yes” answer to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening.
    13. Taking any of the prohibited medications or not meeting the requirements regarding stable doses of permitted medications.
    14. Participation in a clinical study involving any investigational drug/device for DLB within 6 months before Screening or any other investigational drug/device in the 8 weeks or 5 half-lives
    (whichever is longer) of the study medication before Screening unless it can be documented that the subject was in a placebo treatment arm.
    15. Females of childbearing potential.
    (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least 12 consecutive months, in the appropriate age group,
    and without other known or suspected cause] or have been sterilized surgically [ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]).
    16. For subjects who participate in the CSF substudy, the following exclusions apply:
    a. A bleeding disorder that is not under adequate control (including a plate count <50,000, international normalized ratio [INR] >1.5 or partial thromboplastin time [PTT] > upper limit
    of normal [ULN]).
    b. Any contraindications to LP (eg, lower spinal malformation on physical examination, local spinal infection or other abnormality, or obesity to the extent that it makes LP technically difficult).
    1. Enfermedad neurológica que pueda estar contribuyendo al deterioro cognitivo más allá del causado por la DCL del paciente, incluida cualquier enfermedad concomitante detectada en la evaluación clínica o por RMN.
    2. Antecedentes de accidentes isquémicos transitorios o ictus en los 12 meses anteriores a la selección.
    3. Escala isquémica de Hachinski modificada >4.
    4. Características parkinsonianas (extrapiramidales) con estadio de Hoehn y Yahr de IV o superior.
    5. Diagnóstico psiquiátrico importante, como esquizofrenia, trastorno bipolar o trastorno depresivo mayor actual, de acuerdo con la quinta edición del Manual diagnóstico y estadístico de los trastornos mentales (DSM-V).
    6. Puntuación GDS >8.
    7. Evidencia de otras lesiones clínicamente significativas compatibles con un diagnóstico de demencia que no sea DCL en la RMN cerebral de selección. Todas las RMN se obtendrán usando un procedimiento normalizado que se
    que se describirá en el registro de los estudios de representación por imágenes y las directrices para la adquisición de imágenes (IAG), y las interpretará un lector centralizado aprobado.
    8. Otras observaciones patológicas significativas en la RMN cerebral de selección, incluidos, entre otros: macrohemorragia (diámetro máximo superior a 10 mm); área de siderosis superficial; evidencias de contusión cerebral, encefalomalacia, aneurismas, malformaciones arteriovenosas o lesiones infecciosas; evidencias de múltiples infartos lacunares o ictus que afecte a un territorio vascular importante, enfermedad grave de pequeños vasos o de la materia blanca; lesión ocupante de espacio; o tumor cerebral [sin embargo, las lesiones cuyo diagnóstico sea meningioma o quiste aracnoideo y cuyo diámetro máximo sea inferior o igual a 1 cm no serán necesariamente excluyentes])
    9. Hipersensibilidad a E2027 o a cualquiera de los excipientes.
    10. Prolongación del intervalo QT corregido calculado con la fórmula de Fridericia (QTcF) demostrada en un ECG por triplicado en las visitas de selección o iniciales (es decir, valor medio >450 ms).
    11. Hipotensión ortostática sintomática o taquicardia ortostática sintomática que haya causado una hospitalización o revisión médica urgente en el hospital en los 12 meses anteriores a la selección.
    12. Una respuesta afirmativa en el C-SSRS de ideas suicidas de tipo 4 o 5, o en cualquier evaluación de conducta suicida en los 6 meses anteriores a la selección o en la visita de selección o inicial, o haber sido hospitalizado o tratado por conducta suicida en los 5 años anteriores a la selección.
    13. Estar tomando alguno de los medicamentos prohibidos o no cumplir los requisitos de dosis estables de los medicamentos permitidos.
    14. Participación en un ensayo clínico con cualquier fármaco/dispositivo experimental para la DCL en los 6 meses previos a la selección o cualquier otro fármaco/dispositivo experimental en las 8 semanas o 5 semividas
    (lo que sea más largo) de la medicación del estudio antes de la selección, a menos que pueda documentarse que el sujeto estaba en un grupo de tratamiento con placebo.
    15. Mujeres potencialmente fértiles.
    (NOTA: Todas las mujeres se considerarán potencialmente fértiles, salvo que sean posmenopáusicas [amenorréicas durante al menos 12 meses consecutivos, en el grupo de edad adecuado y
    y sin otra causa conocida o sospechada] o hayan sido esterilizadas quirúrgicamente [es decir, ligadura de trompas bilateral, histerectomía total u ovariectomía bilateral y la cirugía se haya practicado al menos un mes antes de la administración del fármaco]).
    16. Se aplicarán los siguientes criterios de exclusión a los pacientes que participan en el subestudio del LCR:
    a. Trastorno hemorrágico que no esté controlado adecuadamente (incluidos recuento plaquetario <50.000, cociente internacional normalizado [INR] >1,5 o tiempo de tromboplastina parcial [TTP] > al límite superior
    de la normalidad [LSN]).
    b. Contraindicación de la PL (por ejemplo, malformación en la parte inferior de la columna en la exploración física, infección vertebral u otras alteraciones locales u obesidad que técnicamente dificulte la realización de la PL).
    E.5 End points
    E.5.1Primary end point(s)
    1- Change from baseline in the MoCA total score at 12 weeks of treatment
    2- CIBIC-Plus scale at 12 weeks of treatment
    1- Cambio desde la visita basal hasta la semana 12 de tratamiento en la puntuación de MoCA.
    2- Escala CIBIC-Plus a las 12 semanas de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    1- Change from baseline at 12 weeks of treatment in the following endpoints:
    o NPI total score, subscores and caregiver or informant distress score
    o MMSE total score
    o CFI score
    2- CGIC-DLB scale at 12 weeks of treatment
    3- Safety and tolerability of E2027
    1- Cambios desde la visita basal a las 12 semanas de tratamiento en los siguientes objetivos:
    a. Puntuación total del NPI, subpuntuaciones y puntuación de angustia del cuidador o informante.
    b. Puntuación total del MMSE.
    c. Puntuación del CFI
    2- Escala CGIC-DLB a las 12 semanas de tratamiento.
    3- Seguridad y tolerabilidad de E20127.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks for : (1) Change from baseline at 12 weeks of treatment in the following endpoints:
    o NPI total score, subscores and caregiver or informant distress score
    o MMSE total score
    o CFI score

    12 weeks for : (2) CGIC-DLB scale at 12 weeks of treatment

    Over the period of 12 weeks for : (3) Safety and tolerability of E2027
    12 semanas para: (1) Cambio desde la visita basal a las 12 semanas de tratamiento en los siguientes objetivos:
    • Puntuación total del NPI, subpuntuaciones y puntuación de angustia del cuidador o informante.
    • Puntuación total del MMSE.
    • Puntuación del CFI
    12 semanas para: (2) Escala CGIC-DLB a las 12 semanas de tratamiento.
    Durante el periodo de 12 semanas para: (3) Seguridad y tolerabilidad de E20127.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as the last subject completing the Follow-Up Visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months20
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 87
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 173
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F. of subjects incapable of giving consent
    As per diagnostic featured of probable DBL subjects may have progressive cognitive decline of sufficient magnitude and prominent or persistent memory impairment which may prevent them from being capable of giving consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 260
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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